End effector assemblies and methods of manufacturing end effector assemblies for treating and/or cutting tissue

ABSTRACT

A method of manufacturing an end effector assembly including first and second energizable portions configured to supply energy to tissue is provided. The method includes forming a substrate including first and second portions interconnected by a connector portion. The substrate is formed as a single integrated component. The method further includes engaging the substrate with an insulative member, and removing the connector portion of the substrate to electrically insulate the first and second portions from one another.

CROSS REFERENCE TO RELATED APPLICATION

The present application claims the benefit of and priority to U.S.Provisional Application Ser. No. 61/829,415, filed on May 31, 2013, theentire contents of which are incorporated herein by reference.

BACKGROUND

Technical Field

The present disclosure relates to surgical devices and, moreparticularly, to end effector assemblies for energy-based surgicaldevices and methods of manufacturing end effector assemblies forenergy-based surgical devices.

Background of Related Art

A surgical forceps is a plier-like device which relies on mechanicalaction between its jaws to grasp, clamp, and constrict tissue.Energy-based surgical forceps utilize both mechanical clamping actionand energy to affect hemostasis by heating tissue to coagulate and/orcauterize tissue. Certain surgical procedures require more than simplycauterizing tissue and rely on the unique combination of clampingpressure, precise energy control and gap distance (i.e., distancebetween opposing jaw members when closed about tissue) to “seal” tissue.Typically, once tissue is sealed, the surgeon has to accurately severthe tissue along the newly formed tissue seal. Accordingly, many tissuesealing devices have been designed which incorporate a knife or blademember which effectively severs the tissue after forming a tissue seal.More recently, tissue sealing devices have incorporated energy-basedcutting features for energy-based tissue division.

SUMMARY

As used herein, the term “distal” refers to the portion that is beingdescribed which is further from a user, while the term “proximal” refersto the portion that is being described which is closer to a user.Further, to the extent consistent, any of the aspects described hereinmay be used in conjunction with any or all of the other aspectsdescribed herein.

In accordance with the present disclosure, a method of manufacturing anend effector assembly including first and second energizable portionsconfigured to supply energy to tissue is provided. The method includesforming a substrate including first and second portions interconnectedby a connector portion. The substrate is formed as a single integratedcomponent. The method further includes engaging the substrate with aninsulative member, and removing the connector portion of the substrateto electrically insulate the first and second portions from one another.

In some aspects of the present disclosure, the substrate is anelectrically-conductive plate.

In some aspects of the present disclosure, the substrate is formed viastamping.

In some aspects of the present disclosure, the substrate is engaged tothe insulative member via overmolding.

In some aspects of the present disclosure, the substrate includes one ormore flanges for overmolding the substrate onto the insulative member.

In some aspects of the present disclosure, the insulative member formsan outer insulative housing supporting the substrate and an insulativespacer disposed between the first and second portions.

In some aspects of the present disclosure, the method further includesperforating the substrate where each of the first and second portionsmeet the connector portion to facilitate removal of the connectorportion.

In some aspects of the present disclosure, the method further includesengaging the insulative member, having the substrate engaged thereon,about a frame.

In some aspects of the present disclosure, the method further includesindependently connecting the first and second portions to a source ofenergy.

In accordance with the present disclosure, a method of manufacturing ajaw member of a surgical forceps is provided. The method includesforming a conductive plate including a first portion configured forsupplying energy to tissue to treat tissue, a second portion configuredfor supplying energy to tissue to cut tissue, and a connector portioninterconnecting the first and second portions. The plate is formed as asingle integrated component. The method further includes engaging theplate with an insulative housing to form a first jaw member, andremoving the connector portion of the plate to electrically insulate thefirst and second portions from one another.

In some aspects of the present disclosure, the plate is formed viastamping.

In some aspects of the present disclosure, the plate is engaged to theinsulative housing via overmolding. Further, the plate may include oneor more flanges for overmolding the plate onto the insulative housing.

In some aspects of the present disclosure, the insulative housing servesas an insulative spacer disposed between the first and second portions.

In some aspects of the present disclosure, the method further includesperforating the plate where each of the first and second portions meetthe connector portion to facilitate removal of the connector portion.

In some aspects of the present disclosure, the method further includesengaging the first jaw member about a first jaw frame. The method mayadditionally include pivotably coupling the first jaw frame to a secondjaw frame such that the first and second jaw frames are movable relativeto one another to grasp tissue between the first jaw member and a secondjaw member disposed about the second jaw frame.

In some aspects of the present disclosure, the method further includesindependently connecting the first and second portions to a source ofenergy.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects and features of the present disclosure are describedherein with reference to the drawings wherein:

FIG. 1 is a front, side, perspective view of an endoscopic surgicalforceps configured for use in accordance with the present disclosure;

FIG. 2 is a front, side, perspective view of an open surgical forcepsconfigured for use in accordance with the present disclosure;

FIG. 3A is a front, side, perspective view of an end effector assemblyconfigured for use with the forceps of FIG. 1 or 2;

FIG. 3B is a transverse, cross-sectional view of the end effectorassembly of FIG. 3A;

FIGS. 4A-4C are transverse-cross-sectional views illustrating themanufacture of a jaw member of an end effector assembly similar to theend effector assembly of FIG. 3A, in accordance with the presentdisclosure; and

FIGS. 5A-5C are top views illustrating the manufacture of the jaw memberof FIGS. 4A-4C.

DETAILED DESCRIPTION

Turning to FIGS. 1 and 2, FIG. 1 depicts a forceps 10 for use inconnection with endoscopic surgical procedures and FIG. 2 depicts anopen forceps 10′ contemplated for use in connection with traditionalopen surgical procedures. For the purposes herein, either an endoscopicdevice, e.g., forceps 10, an open device, e.g., forceps 10′, or anyother suitable surgical device may be utilized in accordance with thepresent disclosure. Obviously, different electrical and mechanicalconnections and considerations apply to each particular type of device,however, the aspects and features of the present disclosure remaingenerally consistent regardless of the particular device used.

Referring to FIG. 1, an endoscopic forceps 10 is provided defining alongitudinal axis “X-X” and including a housing 20, a handle assembly30, a rotating assembly 70, an activation assembly 80, and an endeffector assembly 100. Forceps 10 further includes a shaft 12 having adistal end 14 configured to mechanically engage end effector assembly100 and a proximal end 16 that mechanically engages housing 20. Forceps10 also includes cable 8 that connects forceps 10 to an energy source(not shown), e.g., a generator or other suitable power source, althoughforceps 10 may alternatively be configured as a battery-powered device.Cable 8 includes a wire (or wires) (not shown) extending therethroughthat has sufficient length to extend through shaft 12 in order toprovide energy to at least one of tissue-contacting plates 114, 124(FIG. 3A) of jaw members 110, 120, respectively, as well as toenergy-based cutting member 130 (FIG. 3A) of jaw member 120. Activationassembly 80 includes a two-mode activation switch 82 provided on housing20 for selectively supplying energy to jaw members 110, 120 fortreating, e.g., sealing, tissue (the first mode), and for energy-basedtissue cutting (the second mode).

Handle assembly 30 includes fixed handle 50 and a movable handle 40.Fixed handle 50 is integrally associated with housing 20 and handle 40is movable relative to fixed handle 50. Movable handle 40 of handleassembly 30 is operably coupled to a drive assembly (not shown) that,together, mechanically cooperate to impart movement of jaw members 110,120 between a spaced-apart position and an approximated position tograsp tissue between jaw members 110, 120. More specifically, as shownin FIG. 1, movable handle 40 is initially spaced-apart from fixed handle50 and, correspondingly, jaw members 110, 120 are disposed in thespaced-apart position. Movable handle 40 is depressible from thisinitial position to a depressed position corresponding to theapproximated position of jaw members 110, 120. Rotating assembly 70 isrotatable in either direction about longitudinal axis “X-X” to rotateend effector 100 about longitudinal axis “X-X.”

Referring to FIG. 2, an open forceps 10′ is shown including twoelongated shaft members 12 a, 12 b, each having a proximal end 16 a, 16b, and a distal end 14 a, 14 b, respectively. Forceps 10′ is configuredfor use with an end effector assembly 100′ similar to end effectorassembly 100 (FIG. 1). More specifically, end effector assembly 100′includes first and second jaw members 110′, 120′ attached to respectivedistal ends 14 a, 14 b of shaft members 12 a, 12 b. Jaw members 110′,120′ are pivotably connected about a pivot 103′. Each shaft member 12 a,12 b includes a handle 17 a, 17 b disposed at the proximal end 16 a, 16b thereof. Each handle 17 a, 17 b defines a finger hole 18 a, 18 btherethrough for receiving a finger of the user. As can be appreciated,finger holes 18 a, 18 b facilitate movement of the shaft members 12 a,12 b relative to one another to, in turn, pivot jaw members 110′, 120′from an open position, wherein jaw members 110′, 120′ are disposed inspaced-apart relation relative to one another, to a closed position,wherein jaw members 110′, 120′ cooperate to grasp tissue therebetween.

One of the shaft members 12 a, 12 b of forceps 10′, e.g., shaft member12 a, includes a proximal shaft connector 19 configured to connect theforceps 10′ to a source of energy (not shown), e.g., a generator.Proximal shaft connector 19 secures a cable 8′ to forceps 10′ such thatthe user may selectively supply energy to jaw members 110′, 120′ fortreating, e.g., sealing, tissue, and for energy-based tissue cutting.More specifically, a first activation assembly 80′ is provided forsupplying energy to jaw members 110′, 120′ to treat tissue uponsufficient approximation of shaft members 12 a, 12 b, e.g., uponactivation of activation button 82′ via shaft member 12 b. A secondactivation assembly 84 including a selectively depressible activationbutton 86 is provided on one of the shaft members 12 a, 12 b, e.g.,shaft member 12 b, for selectively supplying energy jaw members 110′,120′ for energy-based tissue cutting.

With reference to FIGS. 3A and 3B, end effector assembly 100 of forceps10 (FIG. 1) is shown, although end effector assembly 100 may similarlybe used in conjunction with forceps 10′ (FIG. 2), or any other suitablesurgical device. For purposes of simplicity, end effector assembly 100is described herein as configured for use with forceps 10 (FIG. 1).

Each jaw member 110, 120 of end effector assembly 100 includes a jawframe 111, 121, an outer insulative jaw housing 112, 122, and atissue-contacting plate 114, 124, respectively. Further, one of the jawmembers 110, 120, e.g., jaw members 120, includes an energy-basedcutting member 130 disposed thereon. Jaw frames 111, 121 each include aproximal flange portion 111 a, 121 a (FIG. 3A) and a distal extensionportion 111 b, 121 b (FIG. 3B), respectively. Proximal flange portions111 a, 121 a of jaw frames 111, 121, respectively, are pivotably coupledto one another about pivot 103 for moving jaw members 110, 120 betweenthe spaced-apart and approximated positions. Distal extension portions111 b, 121 b of jaw frames 111, 121 are configured to support jawhousings 112, 122, and tissue-contacting plates 114, 124, respectively,thereon.

Outer insulative jaw housings 112, 122 of jaw members 110, 120 aredisposed about distal extension portions 111 b, 121 b of jaw frames 111,121 and support and retain tissue-contacting plates 114, 124 onrespective jaw members 110, 120 in opposed relation relative to oneanother. Outer insulative jaw housing 122 of jaw member 120 furthersupports and retains energy-based cutting member 130 on jaw member 120.Tissue-contacting plates 114, 124 are formed from an electricallyconductive material, e.g., for conducting electrical energy therebetweenfor treating tissue, although tissue-contacting plates 114, 124 mayalternatively be configured to conduct any suitable energy throughtissue grasped therebetween for energy-based tissue treatment, e.g.,tissue sealing. Energy-based cutting member 130 is likewise formed froman electrically conductive material, e.g., for conducting electricalenergy between energy-based cutting member 130 and one or both oftissue-contacting plates 114, 124 for electrically cutting tissue,although energy-based cutting member 130 may alternatively be configuredto conduct any suitable energy through tissue for electrically cuttingtissue.

Tissue-contacting plates 114, 124 are coupled to activation switch 82(FIG. 1) and the source of energy (not shown), e.g., via the wires (notshown) extending from cable 8 (FIG. 1) through forceps 10 (FIG. 1), suchthat energy may be selectively supplied to tissue-contacting plate 114and/or tissue-contacting plate 124 and conducted therebetween andthrough tissue disposed between jaw members 110, 120 to treat, e.g.,seal, tissue in a first mode of operation. Likewise, cutting member 130is coupled to activation switch 82 (FIG. 1) and the source of energy(not shown), e.g., via the wires (not shown) extending from cable 8(FIG. 1) through forceps 10 (FIG. 1), such that energy may beselectively supplied to cutting member 130 and conducted through tissuedisposed between jaw members 110, 120 to either or both oftissue-contacting plates 114, 124 to cut tissue in a second mode ofoperation.

Continuing with reference to FIGS. 3A and 3B, cutting member 130 isretained within and extends from a first insulating member 150 disposedwithin a longitudinal slot 126 defined within tissue-contacting plate124 of jaw member 120. More specifically, first insulating member 150surrounds cutting member 130 to insulate tissue-contacting plate 124 andcutting member 130 from one another. A second insulating member 160 isdisposed within a longitudinal slot 116 defined within tissue-contactingplate 114 of jaw member 110 to oppose cutting member 130. Secondinsulating member 160 insulates cutting member 130 fromtissue-contacting plate 114 of jaw member 110 when jaw members 110, 120are disposed in the approximated position. As will be described ingreater detail below, first and second insulating members 160, 150 maybe integrally formed as portions of respective outer insulative jawhousings 112, 122 or may be formed as separate components engaged toouter insulative jaw housings 112, 122, respectively.

As described above, end effector assembly 100 includes first and secondjaw members 110, 120, each including a tissue-contacting plate 114, 124having a longitudinal slot 116, 126, respectively, extendingtherethrough. Cutting member 130 is disposed within longitudinal slot126 of jaw member 120 and opposes longitudinal slot 116 of jaw member110. Ensuring proper alignment and spacing between cutting member 130and tissue-contacting plate 124 helps reduce current concentrations andprovides a more uniform distribution of current flow from cutting member130, through tissue, to tissue-contacting plate 124 and/ortissue-contacting plate 114. As a result, effective energy-based tissuecutting can be more readily achieved and damage to surrounding tissuecan be minimized. Further, proper alignment and spacing between cuttingmember 130 and tissue-contacting plate 124 not only facilitateselectrical cutting, but also facilitates the formation of an effectivetissue seal and minimizes damage to surrounding tissue during conductionof energy between tissue-contacting plates 114, 124.

Turning now to FIGS. 4A-4C and 5A-5C, methods of manufacturing one ormore components of an end effector assembly of an energy-based surgicaldevice are described. As can be appreciated in view of the following,these manufacturing methods help ensure proper alignment and spacingbetween the various components of the end effector assembly, therebyfacilitating effective tissue treatment and/or cutting. For the purposesherein, manufacture of a jaw member similar to jaw member 120 isdescribed below with reference to FIGS. 4A-4C and 5A-5C. However, themanufacturing methods provided in accordance with the present disclosureare equally applicable for use in manufacturing an end effector assemblyor component thereof of any suitable energy-based surgical device.

Initially, as shown in FIGS. 4A and 5A, an electrically-conductivesubstrate 200 (or other suitable substrate configured to energize tissuefor treating and/or cutting tissue) is formed. Substrate 200 may beformed via, for example, stamping, although substrate 200 mayalternatively be formed via molding, punching, blanking, embossing,coining, or other suitable method. Substrate 200 is formed as a single,integral component and includes: a generally U-shaped outer engagementflange 202 defining first and second side portions 203 a, 203 binterconnected by an arc-shaped portion 203 c; a generally U-shapedtissue-contacting segment 204 extending inwardly from outer engagementflange 202 and defining first and second side portions 205 a, 205 binterconnected by an arc-shaped portion 205 c; a generally U-shapedconnector 206 extending inwardly from tissue-contacting segment 204 anddefining first and second side portions 207 a, 207 b interconnected byan arc-shaped portion 207 c; and a central member 208 disposed betweenside portions 207 a, 207 b and arc-shaped portion 207 c oftissue-contact segment 204. Central member 208 defines an innerengagement flange 209 extending therefrom.

As shown in FIGS. 4A and 5A, once substrate 200 is formed (or duringformation of substrate 200), perforations 212, 214 may be formed insubstrate 200 between tissue-contacting segment 204 and connector 206,and between connector 206 and central member 208, respectively.

Referring to FIGS. 4B and 5B, substrate 200, once formed (and/orperforated), is engaged to, e.g., retained and supported on, insulativemember 300. More specifically substrate 200 may be engaged to insulativemember 300 via overmolding insulative member 300 about substrate 200such that outer flange 202 and inner flange 209 are retained within andsurrounded by insulative member 300. Alternatively, substrate 200 may beengaged to insulative member 300 via snap-fitting, adhesion, or anyother suitable method. Prior to, in conjunction with, or afterengagement of substrate 200 and insulative member 300 to one another,insulative member 300 is engaged about jaw frame 400. For example,insulative member 300 may be injection molded about both jaw frame 400and substrate 200 to simultaneously (or near-simultaneously) engage thecomponents to one another. Alternatively, insulative member 300 may beengaged about jaw frame 400, e.g., via snap-fitting, friction fitting,etc., after engagement of insulative member 300 about substrate 200.

Turning now to FIGS. 4C and 5C, with insulative member 300 engaged aboutboth substrate 200, e.g., via the engagement of outer and inner flanges202, 209 within member 300, and jaw frame 400, substrate 200 is retainedin fixed position and orientation relative to itself and to insulativemember 300. In other words, the alignment and spacing of the variousportions of substrate 200 is set. At this point, substrate 200 may bepartitioned by removing connector 206 without disturbing the setalignment and spacing between the various portions of substrate 200.Removal of connector 206 is facilitated by perforations 212, 214 (FIGS.4A, 4B, 5A, and 5B). With connector 206 removed, as shown in FIGS. 4Cand 5C, central member 208 is decoupled from tissue-contacting segment204. More specifically, upon removal of connector 206, central member208 and tissue-contacting segment 204 are spaced-apart and insulatedfrom one another via insulative member 300.

As shown in FIGS. 4C and 5C, and by the above-described manufacturingmethod, a jaw member 500 including a tissue-contacting plate 514 andenergy-based cutting member 530 electrically insulated from one anothervia an insulating member 560 is provided. Advantageously,tissue-contacting plate 514 and energy-based cutting member 530 areproperly aligned and spaced relative to one another, thus facilitatingeffective tissue treatment and/or cutting during use. Further, as can beappreciated in view of the above, insulating member 560 and outerinsulative jaw housing 512 are formed as a single, integral component.However, it is also envisioned that insulating member 560 and outerinsulative jaw housing 512 be provided as separate components.

From the foregoing and with reference to the various figure drawings,those skilled in the art will appreciate that certain modifications canalso be made to the present disclosure without departing from the scopeof the same. While several embodiments of the disclosure have been shownin the drawings, it is not intended that the disclosure be limitedthereto, as it is intended that the disclosure be as broad in scope asthe art will allow and that the specification be read likewise.Therefore, the above description should not be construed as limiting,but merely as exemplifications of particular embodiments. Those skilledin the art will envision other modifications within the scope and spiritof the claims appended hereto.

What is claimed is:
 1. A method of manufacturing an end effectorassembly including first and second energizable portions configured tosupply energy to tissue, the method comprising: forming a substrateincluding first and second portions interconnected by a connectorportion, the substrate formed as a single integrated component, theconnector portion including first and second side portionsinterconnected by an arc-shaped portion; engaging the substrate with aninsulative member; and removing the connector portion of the substrateto electrically insulate the first and second portions from one another.2. The method according to claim 1, wherein the substrate is anelectrically-conductive plate.
 3. The method according to claim 1,wherein the substrate is formed via stamping.
 4. The method according toclaim 1, wherein the substrate is engaged to the insulative member viaovermolding.
 5. The method according to claim 4, wherein the substrateincludes at least one flange for overmolding the substrate onto theinsulative member.
 6. The method according to claim 1, wherein theinsulative member forms an outer insulative housing supporting thesubstrate and an insulative spacer disposed between the first and secondportions.
 7. The method according to claim 1, further comprising thestep of perforating the substrate where each of the first and secondportions meet the connector portion to facilitate removal of theconnector portion.
 8. The method according to claim 1, furthercomprising the step of engaging the insulative member, having thesubstrate engaged thereon, about a frame.
 9. The method according toclaim 1, further comprising the step of independently connecting thefirst and second portions to a source of energy.
 10. A method ofmanufacturing a jaw member of a surgical forceps, comprising: forming aconductive plate including a first portion configured for supplyingenergy to tissue to treat tissue, a second portion configured forsupplying energy to tissue to cut tissue, and a connector portioninterconnecting the first and second portions and including first andsecond side portions, the second portion disposed between the first andsecond side portions of the connector, the plate formed as a singleintegrated component; engaging the plate with an insulative housing toform a first jaw member; and removing the connector portion of the plateto electrically insulate the first and second portions from one another.11. The method according to claim 10, wherein the plate is formed viastamping.
 12. The method according to claim 10, wherein the plate isengaged to the insulative housing via overmolding.
 13. The methodaccording to claim 10, wherein the plate includes at least one flangefor overmolding the plate onto the insulative housing.
 14. The methodaccording to claim 10, wherein the insulative housing serves as aninsulative spacer disposed between the first and second portions. 15.The method according to claim 10, further comprising the step ofperforating the plate where each of the first and second portions meetthe connector portion to facilitate removal of the connector portion.16. The method according to claim 10, further comprising the step ofengaging the first jaw member about a first jaw frame.
 17. The methodaccording to claim 16, further comprising the step of pivotably couplingthe first jaw frame to a second jaw frame such that the first and secondjaw frames are movable relative to one another to grasp tissue betweenthe first jaw member and a second jaw member disposed about the secondjaw frame.
 18. The method according to claim 10, further comprising thestep of independently connecting the first and second portions to asource of energy.
 19. The method according to claim 1, wherein each ofthe first and second side portions of the connector have a first endportion and a second end portion, the arc-shaped portion directlyconnected to the second end portions of each of the first and secondside portions.
 20. The method according to claim 19, wherein the firstand second side portions are oriented parallel to one another.